A Research Study Looking Into How a Single Dose of the Medicine NNC0537-1482 Moves Through the Body of Participants With Normal or Reduced Kidney Function

NCT07808788 | Not Yet Recruiting Phase 1 FDA Drug

• 3 other identifiers: NN6537-8759U1111-1335-36192026-525271-57
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study to find out how the study medicine NNC0537-1482 moves through the body in people living with reduced kidney function compared to people with normal kidney function. All participants will get a single dose of the new medicine. The data for how much medicine is in the blood over time and compare levels between people with reduced and normal kidney function.

Conditions

Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with normal function and mild, moderate and severe impairment

  Measured as hour per nanomoles per liter (h\*nmol/L).

  From pre-dose (Day 1) until Day 36

Secondary Outcomes (6)

• Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with normal function and mild, moderate and severe impairment

  From pre-dose (Day 1) until Day 36

• Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with normal function and mild, moderate and severe impairment

  From pre-dose (Day 1) until Day 36

• Area under the NNC0537-1482 plasma concentration-time curve from 0 hours to the time of the last quantifiable concentration (AUC0-tz) in participant with end-stage renal disease (ESRD)

  From pre-dose (Day 1) until Day 36

• Maximum observed NNC0537-1482 plasma concentration (Cmax) in participant with end-stage renal disease (ESRD)

  From pre-dose (Day 1) until Day 36

• Time to maximum observed NNC0537-1482 plasma concentration (tmax) in participant with end-stage renal disease (ESRD)

  From pre-dose (Day 1) until Day 36

Study Arms (1)

NNC0537-1482

EXPERIMENTAL

Participants will be administered NNC0537-1482 single dose subcutaneously.

Drug: NNC0537-1482; Other: Placebo (for dilution only)

Interventions

NNC0537-1482 DRUG

NNC0537-1482 will be administered subcutaneously.

NNC0537-1482

Placebo (for dilution only) OTHER

A placebo was used for dilution of the investigational medicinal product.

NNC0537-1482

Eligibility Criteria

• Age: 18 Years - 75 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Body Mass Index (BMI) between 18.5 and 39.9 Kilogram per meter square (kg/m\^2) (both inclusive) at screening.
• Normal renal function: greater than or equal to (≥) 90, Mild renal impairment: 60-89, Moderate renal impairment: 30-59, Severe renal impairment: 15-29 not requiring dialysis, ESRD: less than (\<)15 and requiring dialysis treatment.
• All participants in the renal impairment groups should have had chronic kidney disease for at least 3 months prior to screening.
• For participants with ESRD requiring dialysis treatment:
• Current treatment with haemodialysis for at least 3 months prior to screening.

You may not qualify if:

• Any condition which in the investigator's opinion might jeopardise participant's safety or compliance with the protocol.
• Presence or history of any clinically relevant respiratory, metabolic, hepatic, cardiovascular, gastrointestinal, or endocrinological conditions (except conditions associated with renal impairment or ESRD).
• Use of medicinal products known to affect creatinine clearance including cephalosporin and aminoglycoside antibiotics, flucytosine, cisplatin, cimetidine, trimethoprim, cibenzoline, and nitrofurantoin within 14 days or 5 half-lives, whichever is greater, before planned dosing with the investigational medicinal product (IMP).
• Ongoing treatment with nitrates or nitric oxide (NO) donors (for any route; including isosorbide dinitrate, isosorbide 5 mononitrate, pentaerythritol tetranitrate, nicorandil, nitroglycerin , molsidomine), neprilysin inhibitors (including angiotensin receptor/neprilysin inhibitors), phosphodiesterase (PDE) inhibitors (including PDE3, PDE4, PDE5 inhibitors), or soluble guanylate cyclase (sGC) stimulators.
• Note for participants on dialysis: short-term use of nitroglycerin spray for acute hypertensive episodes or emergencies may be permitted at the investigator's discretion if nitroglycerin is administered as single, short acting dose to treat an acute event (i.e., not scheduled, not for chronic/continuous use); dose, time of administration and reason should be documented in the source documents.
• Blood pressure at screening outside the range of 100-145 millimetres of mercury (mmHg) for systolic or outside the range of 50-99 mmHg for diastolic.
• Blood pressure at screening outside the range of 100-160 mmHg for systolic and/or ≥100 mmHg for diastolic.
• Unstable renal function within the last 3 months before screening as judged by the investigator, or acute exacerbation of renal disease within 14 days before screening.

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Charité - Campus Charité Mitte - Charité Research Organisation GmbH

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Transparency dept. 2834

  Organizational Affiliation Enter 'Novo Nordisk A/S

  STUDY DIRECTOR

Central Study Contacts

Novo Nordisk

CONTACT

(+1) 866-867-7178; clinicaltrials@novonordisk.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2026
• First Posted: September 9, 2026
• Study Start: September 4, 2026
• Primary Completion (Estimated): July 6, 2027
• Study Completion (Estimated): July 6, 2027
• Last Updated: September 9, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)